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Cereno Scientific AB (Nasdaq First North: CRNO B) is a biotechnology company focused on developing disease-modifying treatments for rare cardiovascular and pulmonary diseases. The company describes its mission as pioneering treatments to enhance and extend life, with a pipeline of drug candidates designed to address the underlying mechanisms that drive these severe and progressive conditions rather than only managing symptoms.

Cereno Scientific’s work centers on epigenetic modulation, particularly through histone deacetylase (HDAC) inhibition, and on prostacyclin receptor agonism. According to the company, its drug candidates are intended to target key disease-driving processes such as vascular remodeling, fibrosis, inflammation, thrombosis and pulmonary vascular changes that contribute to rare cardiovascular and pulmonary disorders with high unmet medical need.

Core pipeline and therapeutic focus

The company highlights three main drug programs: CS1, CS014 and CS585. CS1 is described as Cereno Scientific’s lead candidate, an orally administered HDAC inhibitor in Phase II clinical development for pulmonary arterial hypertension (PAH). CS1 is being developed as an add-on therapy on top of standard-of-care treatments and is intended to act through epigenetic modulation to target root mechanisms of PAH, including vascular remodeling, fibrosis and inflammation. The company reports that CS1 has shown a favorable safety profile and encouraging disease-modifying signals in a Phase IIa trial, including reverse vascular remodeling, improvements in right heart function and enhanced patient quality of life in patients with PAH.

Cereno Scientific states that CS1 has first-in-class potential in PAH and has received Orphan Drug Designation in both the U.S. and the EU, as well as Fast Track designation from the U.S. Food and Drug Administration (FDA). An Expanded Access Program is in place to enable patients who have completed the Phase IIa trial to continue receiving CS1. The company has also received FDA clearance to initiate a global Phase IIb trial of CS1 in PAH, designed as a randomized, placebo-controlled, dose-finding study to further evaluate efficacy, safety and tolerability when added to standard therapy.

CS014 is described as a next-generation HDAC inhibitor and novel chemical entity (NCE) with disease-modifying potential in severe cardiovascular and pulmonary diseases. Non-clinical studies cited by the company have demonstrated potent effects on pathways involved in vascular remodeling and fibrosis, suggesting potential to influence the course of disease in several cardiovascular and pulmonary conditions. CS014 has completed a Phase I study, which the company reports confirmed a favorable safety and tolerability profile at and above exposure levels predicted from non-clinical data to support maximal effects on the reversal of pulmonary vascular remodeling and fibrosis.

The company indicates that CS014 is being advanced toward Phase II clinical development with an initial focus on idiopathic pulmonary fibrosis (IPF), a severe fibrotic lung disease. CS014 is characterized as an HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator, with the potential to address underlying pathophysiology in rare cardiovascular and pulmonary diseases with high unmet needs. Peer-reviewed data published on CS014 describe it as a novel HDAC inhibitor engineered to improve upon valproic acid by reducing hepatotoxicity risk while preserving HDAC inhibition benefits, with non-clinical models showing antithrombotic efficacy without increased bleeding risk and lower levels of a hepatotoxic metabolite compared with valproic acid.

CS585 is a preclinical-stage candidate that Cereno Scientific describes as an oral, highly potent and selective prostacyclin (IP) receptor agonist. According to the company, CS585 has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases in preclinical studies. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data cited by the company indicate that it could potentially be used in indications such as thrombosis prevention without increased risk of bleeding.

Disease areas and medical need

Cereno Scientific emphasizes its focus on rare cardiovascular and pulmonary diseases with high unmet medical need. In particular, the company highlights pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) as key target indications within its pipeline. PAH is described as a rare, progressive and life-threatening disease characterized by high blood pressure in the pulmonary arteries, leading to right heart failure and premature death. The company notes that current standard treatments mainly focus on symptom management, leaving a need for therapies that can modify disease progression.

For PAH, Cereno Scientific’s approach with CS1 is to target the root mechanisms of disease through epigenetic modulation rather than focusing solely on symptomatic relief. For IPF and related fibrotic or thrombotic conditions, CS014 is being developed to modulate epigenetic pathways and pathways involved in vascular remodeling and fibrosis, with the goal of addressing underlying disease processes. Across its programs, the company positions its candidates as disease-modifying drug candidates that may offer benefits in terms of vascular remodeling, thrombosis control, fibrosis and inflammation in rare cardiopulmonary conditions.

Geographic footprint and listing

Cereno Scientific AB states that it is headquartered in GoCo Health Innovation City in Gothenburg, Sweden. The company also has a U.S. subsidiary, Cereno Scientific Inc., based in Kendall Square, Boston, Massachusetts.> This presence in both Europe and the United States supports its global clinical development plans, including multicenter trials across multiple regions.

The company’s shares are listed on the Nasdaq First North growth market under the ticker CRNO B. In its communications, Cereno Scientific identifies DNB Carnegie Investment Bank AB as its Certified Adviser for the Nasdaq First North listing.

Regulatory and clinical development highlights

According to company announcements, CS1 has achieved several regulatory milestones. These include Orphan Drug Designation in the U.S. and EU for PAH and Fast Track designation from the U.S. FDA, reflecting recognition of PAH as a serious condition with high unmet medical need and of CS1’s potential as a therapy. The company has submitted and received FDA clearance for a global Phase IIb trial protocol in PAH, described as the largest and most comprehensive clinical program undertaken by Cereno Scientific to date.

The planned Phase IIb trial is outlined as a double-blind, randomized, placebo-controlled, dose-finding study comparing CS1 versus placebo when added to standard of care in patients with PAH who are stable on background therapy. The trial is expected to evaluate effects on pulmonary vascular resistance, exercise capacity and additional clinical and biomarker endpoints, with a design that allows all participants to receive active treatment at some point during the study. These details illustrate the company’s strategy to build on prior Phase IIa findings and to generate data that can inform potential Phase III development.

For CS014, Cereno Scientific highlights the completion of a Phase I study demonstrating a favorable safety profile and tolerability, supporting advancement into Phase II clinical development. The company also points to peer-reviewed publication of non-clinical data describing CS014’s HDAC inhibition, antithrombotic activity without increased bleeding risk, effects on tissue plasminogen activator (tPA) mRNA expression and reduced formation of a hepatotoxic metabolite compared with valproic acid in in vitro and in vivo systems.

Research platform and scientific positioning

Cereno Scientific describes its HDAC inhibitor platform as central to its strategy in rare cardiovascular and pulmonary diseases. Through epigenetic modulation, the company aims to influence gene expression patterns and biological pathways involved in vascular remodeling, fibrosis, inflammation and thrombosis. CS1 and CS014 exemplify this approach, with CS1 focused on PAH and CS014 on broader cardiovascular and pulmonary indications such as IPF and thrombotic and fibrosis-driven diseases.

The company also notes that published data and regulatory designations are important components in its discussions with potential partners, regulators and the broader scientific community. Peer-reviewed publications, such as the manuscript on CS014 in the Journal of Thrombosis and Haemostasis, are cited as validating the underlying mechanisms and supporting the therapeutic potential of its HDAC inhibitor platform.

Business model and development stage

Based on its public communications, Cereno Scientific operates as a clinical-stage biotech company. Its business activities are centered on advancing its pipeline of drug candidates through preclinical and clinical development, obtaining regulatory designations and clearances, and engaging with partners, investors and scientific stakeholders at industry events and conferences. The company highlights participation in major life science gatherings such as JPM Week and the Biotech Showcase as part of its efforts to build strategic relationships and explore partnering opportunities related to its HDAC inhibitor portfolio and prostacyclin receptor agonist program.

As a biotech focused on rare diseases, Cereno Scientific’s value proposition, as described in its announcements, is tied to the potential of its candidates to modify disease course in conditions with limited effective treatment options, such as PAH and IPF. The emphasis on disease-modifying mechanisms, regulatory designations and clinical trial progression reflects the company’s development-driven model.

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